Endoluminal fundoplication device and related method

ABSTRACT

A distal assembly of an endoscopic surgical device, and a related method, having a first arm and a second arm pivotal relative to the first arm. Each arm is configured to hold a part of a two-part fastener at a distal end of the arm. A closing mechanism is positioned proximate a proximal end of each of the first and second arms opposite the distal end of each of the first and second arms. The closing mechanism is configured to move in relation to the first and second arms so as to close over at least one of the first and second arms to cause the distal ends of the arms to come together. An actuation member is also attached to the closing mechanism actuable to cause the closing mechanism to move in relation to the first and second arms.

DESCRIPTION OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The invention relates to an endoscopic surgical instrument. Moreparticularly, the invention relates to a flexible instrument fortransoral invagination and fundoplication of the stomach to theesophagus.

[0003] 2. Background of the Invention

[0004] Gastroesophageal reflux occurs when stomach acid enters theesophagus. This reflux of acid into the esophagus occurs naturally inhealthy individuals, but also may become a pathological condition inothers. Effects from gastroesophageal reflux range from mild to severe.Mild effects include heartburn, a burning sensation experienced behindthe breastbone. More severe effects include a variety of complications,such as esophageal erosion, esophageal ulcers, esophageal stricture,abnormal epithelium (e.g., Barrett's esophagus), and/or pulmonaryaspiration. These various clinical conditions and changes in tissuestructure that result from reflux of stomach acid into the esophagus arereferred to generally as Gastro-esophageal Reflux Disease (GERD).

[0005] Many mechanisms contribute to prevent gastroesophageal reflux inhealthy individuals. One such mechanism is the functioning of the loweresophageal sphincter (LES). The LES is a ring of smooth muscle andincreased annular thickness existing in the last four centimeters of theesophagus. In its resting state, the LES creates a region of highpressure (approximately 15-30 mm Hg above intragastric pressure) at theopening of the esophagus into the stomach. This pressure essentiallycloses the esophagus contents of the stomach cannot pass back into theesophagus. The LES opens in response to swallowing and peristalticmotion in the esophagus, allowing food to pass into the stomach. Afteropening, however, a properly functioning LES should return to theresting, or closed state. Transient relaxations of the LES do occur inhealthy individuals, typically resulting in occasional bouts ofheartburn.

[0006] The physical interaction occurring between the gastric fundus andthe esophagus also prevents gastroesophageal reflux. The gastric fundusis a lobe of the stomach situated at the top of the stomach distal tothe esophagus. In asymptomatic individuals, the fundus presses againstthe opening of the esophagus when the stomach is full of food and/orgas. This effectively closes off the esophageal opening to the stomachand helps to prevent acid reflux back into the esophagus. Morespecifically, as the food bolus is immersed in gastric acid, it releasesgas which causes the fundus of the stomach to expand and thereby putpressure on the distal esophagus causing it to collapse. The collapse ofthe esophagus lumen reduces the space for the stomach acid to splashpast the closed esophagus lumen and thereby protect the proximalesophagus from its destructive contact.

[0007] In individuals with GERD, the LES functions abnormally, eitherdue to an increase in transient LES relaxations, decreased muscle toneof the LES during resting, or an inability of the esophageal tissue toresist injury or repair itself after injury. These conditions often areexacerbated by overeating, intake of caffeine, chocolate or fatty foods,smoking, and/or hiatal hernia. Avoiding these exacerbating mechanismshelps curb the negative side effects associated with GERD, but does notchange the underlying disease mechanism.

[0008] A surgical procedure has been developed to prevent acid reflux inpatients whose normal LES functioning has been impaired. This procedure,a Nissen fundoplication, involves bringing the fundus into closerproximity to the esophagus and suturing the fundus thereto, to helpclose off the esophageal opening into the stomach. Traditionally, thisprocedure has been performed as an open surgery, but also has beenperformed laparoscopically.

[0009] As with any surgery, the attendant risks are great. The Nissenfundoplication is a very difficult procedure to complete and thus thepatient is anesthitized for a long time. Due to relatively largeincisions necessary in the performance of open surgery, relatively largeamounts of blood are lost, the risk of infection increases and thepotential for post-operative hernias is high.

[0010] A laparoscopic procedure may involve performing laparotomies fortrocar ports (penetrations of the abdominal wall) percutaneousendoscopic gastronomies (incisions through the skin into the stomach)and the installation of ports through which, for example, a stapler, anendoscope, and an esophageal manipulator (invagination device) areinserted. Under view of the endoscope, the esophageal manipulator isused to pull the interior of the esophagus into the stomach. When theesophagus is in position, with the fundus of the stomach plicated, thestapler is moved into position around the lower end of the esophagus andthe plicated fundus is stapled to the esophagus. The process may berepeated at different axial and rotary positions until the desiredfundoplication is achieved. This procedure is still relatively invasiverequiring incisions through the stomach, which has a risk of infection.The location of the incision in the abdominal wall presents a risk ofother negative effects, such as sepsis which can be caused by leakage ofseptic fluid contained in the stomach.

[0011] Less invasive treatments of gastroesophageal reflux disease mayutilize a remotely operable invagination device and a remotely operablesurgical stapler, both of which are inserted transorally through theesophagus. The invagination device may be inserted first and used toclamp the gastroesophageal junction. The device is then moved distally,pulling the clamped gastroesophageal junction into the stomach, therebyinvaginating the junction and involuting the surrounding fundic wall.The stapler then may be inserted transorally and delivered to theinvaginated junction where it is used to staple the fundic wall. Thestapling device must apply sufficient force to pierce the tissue that isto be fastened.

SUMMARY OF THE INVENTION

[0012] In accordance with one aspect of the invention, a distal assemblyof an endoscopic surgical device is provided having a first arm and asecond arm pivotal relative to the first arm. Each arm is configured tohold a part of a two-part fastener at a distal end of the arm. A closingmechanism is positioned proximate a proximal end of each of the firstand second arms opposite the distal end of each of the first and secondarms. The closing mechanism is configured to move in relation to thefirst and second arms so as to close over at least one of the first andsecond arms to cause the distal ends of the arms to come together. Anactuation member is also attached to the closing mechanism and isactuable to cause the closing mechanism to move in relation to the firstand second arms.

[0013] According to another aspect of the invention, a tissue fasteningtool is utilized with an endoscope. The endoscope is provided with astop mechanism to come in contact with the distal assembly and stop thedistal assembly at a predetermined location along the endoscope.

[0014] According to yet another aspect of the invention, an endoscopemay be provided with a housing that contains two light and imagingsystems, one facing in a distal direction and the other facing in aproximal direction opposite the distal direction.

[0015] Another aspect of the invention includes a method for fastingtissue that includes guiding a tissue fastening tool along an endoscopeuntil the tissue fastening tool contacts a stop mechanism so as toposition the tissue fastening tool relative to the endoscope. The tissuefastening tool has a pair of arms and each of the arms holds a part of atwo-part fastener. The operator then positions the pair of arms aboutthe tissue to be fastened and the arms are then closed to deploy thetwo-part fastener and fasten the tissue.

[0016] According to another aspect, the invention includes a method forfastening tissue that includes guiding a tissue fastening tool through abody lumen to tissue to be fastened. The tissue fasting tool includes apair of arms, each arm holding a part of a two-part fastener. The pairof arms is then positioned about the tissue to be fastened. A closingmechanism is then actuated to close over at least one of the arms tocause the arms to come together and the parts of the two-part fastenerto mate and fasten the tissue.

[0017] Additional objects and advantages of the invention will be setforth in part in the description which follows, and in part will beobvious from the description, or may be learned by practice of theinvention. The objects and advantages of the invention will be realizedand attained by means of the elements and combinations particularlypointed out in the appended claims. The foregoing general descriptionand the following detailed description are exemplary and explanatoryonly and are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The accompanying drawings, which are incorporated in andconstitute a part of this specification, illustrate embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

[0019]FIG. 1 is a plan view of a distal end of a fastener applicationtool according to an embodiment of the present invention.

[0020]FIG. 2 is a view of the fastener application tool of FIG. 1affixed to a sleeve and in place over an endoscope.

[0021]FIG. 2A is a cross-sectional view along line A-A of the fastenerapplication tool of FIG. 2 that has been rotated 90° from theorientation shown in FIG. 2.

[0022]FIG. 3 is a view of the fastener application tool of FIG. 1 inplace over an endoscope and having a stop ring to accurately positionthe tool for performing the surgical procedure.

[0023]FIG. 4 is a view showing the fastener application tool andendoscope of FIG. 2, with the tool in a deployed position inserting afastener through the tissue.

[0024]FIG. 5 is a plan view of a distal end of an endoscope according toan embodiment of the present invention.

[0025]FIG. 6 is an end view of the fastener application tool in place ona sleeve showing the dovetailed connection between the sleeve and tool.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] Reference will now be made in detail to the present preferred andexemplary embodiments of the invention, examples of which areillustrated in the accompanying drawings. Wherever possible, the samereference numbers will be used throughout the drawings to refer to thesame or like parts.

[0027]FIG. 1 shows a distal end of a tissue fastener application tool 10according to an embodiment of the present invention. In this figure,tool 10 is in an intermediate position between a fully open position anda deployed position where the tool deploys a fastener to secure a tissuefold. Tool 10 preferably is used endoscopically, by insertiontransorally through the esophagus, to fasten the fundic wall with atissue fastener. Tool 10 includes a pair of pivot arms 12, 14 configuredto pivot about a pivot point 16 located at a proximal end of arms 12,14. Beneath arm 12 is located flange 11. Flange 11 is preferably shapedto fit into a groove located within sleeve 30 (shown in FIG. 2). Thisflange and groove is depicted in FIG. 2A as a dove-tail joint, but maybe any other mating configuration known in the art. At a distal end ofarm 12 is a holding mechanism for holding a female part 40 of a two-parttissue fastener. Likewise, at the distal end of arm 14 is a holdingmechanism to hold a male part 42 of the two-part tissue fastener. Thefemale and male fastener parts 40,42 could be located on either pivotarm and are not intended to be limited to the configuration disclosed inthe drawings. The two-part tissue fastener and its holding mechanismsmay take the form of any suitable tissue fastener and holding mechanismknown in the art, including, for example, holding mechanisms thatinclude storage for housing multiple fastener parts

[0028] Tool 10 further includes a closing tube 18 positioned over theproximal end of pivot arms 12,14 where the arms intersect at pivot point16. A spring device may be located at pivot point 16 to supply a springforce to normally hold arms 12,14 in an open position when closing tube18 is in a retracted position, such as that shown in FIG. 2. Arm 12preferably is in a fixed position relative to tube 18 and arm 14 rotatesfrom an open position (FIG. 2) to a closed position (FIG. 3) relative toarm 12. Tube 18 is hollow to accommodate arms 12,14 and the full span ofrotation of arm 14.

[0029] Closing tube 18 is connected to an elongate actuator, such as acable 20, which connects to a proximal actuator (not shown) of anysuitable type well known in the art, so that a user may pull a proximalend of cable 20 that is outside the patient, or actuate a proximalactuator to do so, to pull tube 18 toward the distal ends of pivot arms12,14 and thus over arms 12,14. This causes arm 14 to pivot at point 16and towards arm 12 to cause fastener parts 40,42 to mate and secure atissue fold. Arm 12 is provided with a channel 13 into which the base ofclosing tube 18 rests. This channel, along with a matching protrusion 15(FIG. 2A) provided at the base of closing tube 18 provides a path alongwhich closing tube may move to facilitate the closing action that bringsarms 12 and 14 together to deploy fastener parts 40 and 42.

[0030] Pivot arm 14 is preferably curved as depicted in the drawings soas to allow tube 18 to close more easily and apply sufficient force tothe fastener parts. Also, the inside of closing tube 18 may be providedwith a cam surface 19 that is substantially the same shape as arm 14 toact as a cam and provide an even greater closing force to be applied toarms 12 and 14. Arm 14, however, may be straight or have any othersuitable configuration. In addition, arm 12 may be arranged so that itpivots toward arm 14 when tube 18 is closed. The arrangement of thedistal end of the tool 10 provides a high mechanical advantage on thearms to produce a sufficient closing force.

[0031] Tissue fastener application tool 10 preferably is used incombination with an endoscope, such as an endoscope 2 according to anembodiment of the present invention and shown in FIGS. 2 and 3.Endoscope 2 preferably is a small diameter endoscope that incorporatesfeatures needed for the surgical procedure, for example visualization(including imaging and a light source), insufflation, and/orsteerability. Additional endoscope features, such as working channelsfor a biopsy device, may be eliminated so that the endoscope size isreduced, permitting the tissue fastener application tool to passadjacent the endoscope within the lumen of the esophagus. Endoscope 2may be approximately 3 mm in diameter, for example and include a lightsource 3 at its distal end that is capable of illuminating the uppergastrointestinal region. Endoscope 2 may also include an appropriatesteering mechanism so that the distal end of the endoscope may be turned180 degrees upon entry into the stomach, as shown in FIGS. 2 and 3.

[0032] In another embodiment shown in FIG. 4, endoscope 2 may includealternative light and imaging/camera assembly 60. Rather than requiringthe endoscope to curve around at the distal end through use of asteering mechanism, endoscope 2 could have light and imaging/cameraassembly 60, in the form of a housing, at the distal end that allowsboth forward viewing as endoscope 2 is inserted into the stomach as wellas rearward viewing to allow the operator to see the procedure onceendoscope 2 is in the proper position. Assembly 60 may include astandard camera and light source 62 pointing away from the distal end ofassembly 60 and also a second camera and light source 64 that branchesoff of endoscope 2 and points rearward (or proximally) toward the toolto be used in the procedure. A user may switch imaging and light througha suitable switch at the proximal end outside the patient between theseforward and rearward views. This configuration allows for a streamlinedendoscope and does not require the operator to change the position ofthe distal end of endoscope 2 to bring it from a forward pointingposition during insertion to a rearward pointing position during theprocedure.

[0033] In an embodiment, endoscope 2 may be used as a guide, like aguide wire, for the insertion of the tissue fastener application tool,as will be explained. Endoscope 2 also may include a stop, such as thatshown in FIGS. 2 and 3, in the form of, for example, a ring 6 configuredto set the position of tool 10 relative to endoscope 2.

[0034] In operation, and according to an embodiment of a method of thepresent invention, endoscope 2 is inserted transorally, through theesophagus, and into the stomach. Endoscope 2 is manipulated so that theimaging and light source is in a position to view the esophagus andupper portions of the stomach, as shown in FIGS. 2 and 3. If anendoscope having a distal assembly as shown in FIG. 4 is used, cameraand light source 64 is switched on to view those portions of thegastrointestinal tract. The tissue fastener application tool 10 then isinserted into the esophagus along endoscope 2.

[0035] As tool 10 is inserted through the esophagus and into thestomach, arms 12,14 preferably are in a closed position. Tool 10 isinserted until a portion of the distal end of sleeve 30 abuts againststop ring 6 of endoscope 2 so that tool 10 is at an appropriate positionrelative to endoscope 2 and its imaging and light assembly. Once tool 10is in position, tube 18 is moved over arms 12,14 and towards theproximal ends of arms 12, 14 to rotate arm 14 to an open position awayfrom arm 12. Endoscope 2 and tool 10 can then be moved proximally as aunit so that arms 12,14 are opened about a tissue fold 50 that is to befastened together, as shown in FIG. 2.

[0036] During insertion, cable 20 is actuated to keep tube 18 over arms12,14 to maintain this closed position. Because tool 10 is preferably ina closed position during insertion, a spring may be provided in channel13 that would bias tube 18 into an open position once cable 20 isreleased. Once the tool is in position, the operator may release cable20, thus causing closing tube 18 to move toward the distal ends of arms12,14. As tube 18 moves closer to the distal ends of arms 12,14, forceis applied until the two fastener parts 40, 42 are brought together in amated position as seen in FIG. 3. As closing tube 18 is actuated bypulling cable 20, it will counteract the force of the spring at pivot 16and bring pivot arms 12, 14 together to mate the fastener parts 40,42.

[0037] According to an embodiment of the this invention, tube 18 mayinclude an alternative assembly for closing arms 12,14. Instead of cable20 being used to pull closing tube 18 to cause pivot arms 12,14 toclose, cable 20 may be replaced with a flexible shaft having a threadeddistal end that is inserted into a threaded hole in tube 18. In thisconfiguration, the flexible shaft is rotated in one direction to causethe threaded portions of both the shaft and closing tube 18 to worktogether to draw closing tube 18 toward the distal ends of pivot arms12,14 to cause fastener parts 40,42 to mate. Cable 20 may then berotated in the opposite direction to move closing tube 18 distally awayfrom arms 12, 14, thus allowing arms 12, 14 to move apart again. Tube 18may include any other suitable alternative actuation mechanism thatmoves tube 18 over arms 12,14.

[0038] Other embodiments of the invention will be apparent to thoseskilled in the art from consideration of the specification and practiceof the invention disclosed herein. The specification and examples areexemplary only, with a true scope and spirit of the invention beingindicated by the following claims.

What is claimed is:
 1. A distal assembly of an endoscopic surgicaldevice, comprising: a first arm and a second arm pivotal relative to thefirst arm, each arm configured to hold a part of a two-part fastener ata distal end of the arm; a closing mechanism positioned proximate aproximal end of each of the first and second arms opposite the distalend of each of the first and second arms, the closing mechanismconfigured to move in relation to the first and second arms so as toclose over at least one of the first and second arms to cause the distalends of the arms to come together; and an actuation member attached tothe closing mechanism actuable to cause the closing mechanism to move inrelation to the first and second arms.
 2. The distal assembly of claim1, wherein the actuation member is a cable.
 3. The distal assembly ofclaim 1, wherein each of the first and second arms is straight.
 4. Thedistal assembly of claim 1, wherein one of the first and second arms iscurved.
 5. The distal assembly of claim 4, wherein the closing mechanismis configured to close over the curved arm.
 6. The distal assembly ofclaim 1, further comprising a spring at a pivot between the first andsecond arms.
 7. The distal assembly of claim 6, wherein the springprovides a force to cause the distal ends of the arms to be pushedapart.
 8. The distal assembly of claim 1, wherein the actuation memberincludes an elongate member having a threaded end that mates with athreaded hole in the closing mechanism.
 9. The distal assembly of claim1, wherein the closing mechanism includes a tube.
 10. An assembly forendoscopically deploying a two-part fastener, comprising: a flexibleendoscope; a tissue fastening tool configured to be guided along theendoscope; and a stop mechanism located on the endoscope and configuredto stop the advancement of the tissue fastening tool at a locationrelative to the endoscope.
 11. The assembly of claim 10, wherein thestop mechanism includes a ring.
 12. The assembly of claim 10, whereinthe tissue fastening tool includes: a first arm and a second arm pivotalrelative to the first arm, each arm configured to hold a part of thetwo-part fastener at a distal end of the arm; a closing mechanismpositioned proximate a proximal end of each of the first and second armsopposite the distal end of each of the first and second arms, theclosing mechanism configured to move in relation to the first and secondarms so as to close over at least one of the first and second arms tocause the distal ends of the arms to come together; and an actuationmember attached to the closing mechanism actuable to cause the closingmechanism to move in relation to the first and second arms.
 13. Theassembly of claim 12, wherein the actuation member is a cable.
 14. Theassembly of claim 12, wherein each of the first and second arms isstraight.
 15. The assembly of claim 12, wherein one of the first andsecond arms is curved.
 16. The assembly of claim 15, wherein the closingmechanism is configured to close over the curved arm.
 17. The assemblyof claim 12, further comprising a spring at a pivot between the firstand second arms.
 18. The assembly of claim 17, wherein the springprovides a force to cause the distal ends of the arms to be pushedapart.
 19. The assembly of claim 12, wherein the actuation memberincludes an elongate member having a threaded end that mates with athreaded hole in the closing mechanism.
 20. The assembly of claim 12,wherein the closing mechanism includes a tube.
 21. The assembly of claim10, wherein the endoscope further comprises a distal assembly includinga housing having a first light source and imaging system facing a distaldirection and a second light source and imaging system facing a proximaldirection opposite the distal direction.
 22. A distal assembly of anendoscope, comprising: a housing having a first light source and imagingsystem facing a distal direction and a second light source and imagingsystem facing a proximal direction opposite the distal direction.
 23. Amethod for fastening tissue, comprising the steps of: guiding a tissuefastening tool along an endoscope until the tissue fastening toolcontacts a stop mechanism so as to position the tissue fastening toolrelative to the endoscope, wherein the tissue fastening tool includes apair of arms, each arm holding a part of a two-part fastener;positioning the pair of arms about the tissue to be fastened; andclosing the arms to deploy the two-part fastener and fasten the tissue.24. The method of claim 23, further comprising turning a distal end ofthe endoscope to face the tissue fastening tool and the tissue to befastened.
 25. The method of claim 23, further comprising the step ofswitching from a first light source and imaging system of the endoscopethat faces a distal direction and a second light source and imagingsystem of the endoscope that faces a proximal direction opposite thedistal direction.
 26. The method of claim 23, further comprising thestep of actuating a closing mechanism to move in relation to the arms soas to close over at least one of the arms and cause the arms to cometogether.
 27. The method of claim 26, wherein actuating the closingmechanism includes pulling on a cable attached to the closing mechanism.28. The method of claim 26, wherein actuating the closing mechanismincludes rotating a shaft with a threaded end that is coupled to theclosing mechanism.
 29. The method of claim 23, wherein the pair of armsare in a substantially closed configuration during the guiding step. 30.The method of claim 29, further comprising the step of opening the armsprior to the position step.
 31. A method for fastening tissue,comprising the steps of: guiding a tissue fastening tool through a bodylumen to tissue to be fastened, wherein the tissue fasting tool includesa pair of arms, each arm holding a part of a two-part fastener;positioning the pair of arms about the tissue to be fastened; andactuating a closing mechanism to close over at least one of the arms tocause the arms to come together and the parts of the two-part fastenerto mate and fasten the tissue.
 32. The method of claim 31, whereinactuating the closing mechanism includes pulling on a cable attached tothe closing mechanism.
 33. The method of claim 31, wherein actuating theclosing mechanism includes rotating a flexible shaft with a threaded endthat coupled to the closing mechanism.
 34. The method of claim 31,wherein the arms are in a substantially closed configuration during theguiding step.
 35. The method of claim 34, further comprising the step ofopening the arms prior to the positioning step.
 36. The method of claim31, wherein the guiding step includes guiding the tissue fastening toolalong an endoscope.